Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
- Conditions
- Brain Injuries
- Interventions
- Drug: Lipid emulsion without progesterone
- Registration Number
- NCT01143064
- Lead Sponsor
- BHR Pharma, LLC
- Brief Summary
The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1195
- Male or female patients between the age of 16 and 70 years, inclusive
- Weight from 45 to 135 kg, inclusive
- Sustained a closed head trauma no more than 8 hours before start of study drug infusion
- TBI diagnosed by history and clinical examination
- Post-resuscitation Glasgow Coma Scale (GCS) score between 3 to 8, inclusive
- At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive)
- Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification)
- Indication for ICP monitoring
- Life expectancy of less than 24 hours as determined by the Investigator
- Prolonged and/or uncorrectable hypoxia (Pa02< 60 mmHg) or hypotension (systolic blood pressure < 90 mmHg) at the time of randomization
- Any spinal cord injury
- Pregnancy
- Penetrating head injury
- Bilaterally fixed dilated pupils at the time of randomization
- Coma suspected to be primarily due to other causes (e.g. alcohol)
- Pure epidural hematoma
- Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome
- Severe cardiac or hemodynamic instability prior to randomization
- Known treatment with another investigational drug therapy or procedure within 30 days of injury
- A history of allergic reaction to progesterone and related drugs or any of the components of the infusion
- Any disease, in the opinion of the Investigator, that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
- Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol through the final visit (6 months post-injury)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Progesterone Progesterone - Lipid emulsion without progestrone Lipid emulsion without progesterone -
- Primary Outcome Measures
Name Time Method Glasgow Outcome Scale (GOS) 6 months The GOS assesses mortality and disability in traumatic brain injury (TBI) patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead.
- Secondary Outcome Measures
Name Time Method Mortality at Month 1 1 month post injury The mortality rate at one month will be compared between the two treatment groups.
Mortality at Month 6 6 months post injury The mortality rate at six months will be compared between the two treatment groups.
Glasgow Outcome Scale at 3 Months Month 3 The GOS assesses the mortality and disability in traumatic brain injury patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State, or Dead.
Glasgow Outcome Scale - Extended (GOS-E) 3 months and 6 months post injury The GOS-E assessment of mortality and disability in TBI patients extends the original five GOS categories of functional outcome to eight categories:
* Dead
* Vegetative State
* Lower Severe Disability
* Upper Severe Disability
* Lower Moderate Disability
* Upper Moderate Disability
* Lower Good Recovery
* Upper Good RecoveryShort Form (36) Health Survey (SF-36) 3 months and 6 months post injury The Short Form (36) Health Survey (SF-36) is a validated survey of patient health consisting of eight scaled scores which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, role physical, role emotional, role mental and mental health. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The 8 scales can also be further summarized to provide a summary score for physical health and a summary score for mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Potentially Clinically Important On-Treatment Cerebral Perfusion Pressure (CPP) and Summary of Maximum Therapy Therapeutic Intensity Level (TIL) Admission through post-infusion Day 6 Cerebral Perfusion Pressure (CPP) levels are presented according to clinically significant cut-off values. CPP was calculated from intracranial pressures and mean arterial pressures measured from Day through Day 6 after initiation of study medication, if an ICP monitor was in place. Specific therapies received during Days 1-6 are summarized according to the Therapeutic Intensity Level (TIL) by treatment group, as maximum level of therapy administered to the subject.
Trial Locations
- Locations (156)
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
LAC+USC Medical Center
🇺🇸Los Angeles, California, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Christiana Care Health System Hospital
🇺🇸Newark, Delaware, United States
Delray Medical Center
🇺🇸Delray Beach, Florida, United States
Tallahassee Memorial Healthcare
🇺🇸Tallahassee, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Saint Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
John H. Stroger Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Saint John's Hospital
🇺🇸Springfield, Illinois, United States
Wishard Health Services
🇺🇸Indianapolis, Indiana, United States
Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Mercy Medical Center
🇺🇸Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
LSU Health - Shreveport
🇺🇸Shreveport, Louisiana, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
St. Mary's of Michigan
🇺🇸Saginaw, Michigan, United States
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Truman Medical Center Hospital Hill
🇺🇸Kansas City, Missouri, United States
Lester E. Cox Memorial Hospital
🇺🇸Springfield, Missouri, United States
The Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Albany Medical Center Hospital
🇺🇸Albany, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Wake Forest University-Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Summa Health System
🇺🇸Akron, Ohio, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
St. Elizabeth Health Center
🇺🇸Youngstown, Ohio, United States
OU Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital & Health Center
🇺🇸Portland, Oregon, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of South Carolina School of Medicine
🇺🇸Columbia, South Carolina, United States
Johnson City Medical Center
🇺🇸Johnson City, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Marshall University Joan C. Edwards School of Medicine
🇺🇸Huntington, West Virginia, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Hospital Francisco Lopez Lima
🇦🇷General Roca, Rio Negro, Argentina
Hospital de Emergencias Clemente Alvarez (HECA)
🇦🇷Rosario, Santa Fe, Argentina
Hospital Nacional "Profesor Alejandro Posadas"
🇦🇷Buenos Aires, Argentina
Hospital Regional De Comodoro Rivadavia (HRCR)
🇦🇷Comodoro Rivadavia, Argentina
Hospital Central de Mendoza
🇦🇷Mendoza, Argentina
Hospital San Martin
🇦🇷Paraná, Argentina
Hospital Dr. José Maria Cullen
🇦🇷Santa Fé, Argentina
Medizinische Universität Graz
🇦🇹Graz, Austria
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria
Unfallkrankenhaus Salzburg
🇦🇹Salzburg, Austria
Landesklinikum Wiener Neustadt
🇦🇹Vienna, Austria
ULB Erasme
🇧🇪Brussels, Belgium
Ziekenhuis Oost-Limburg, Location Sint Jan
🇧🇪Genk, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
University Hospital of the Free University Brussels (UZ Brussel)
🇧🇪Jette, Belgium
University Hospital Gasthuisberg
🇧🇪Leuven, Belgium
Chengdu Military General Hospital
🇨🇳Chengdu, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, China
The 2nd Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, China
The Second Hospital of Shandong University
🇨🇳Jinan, China
Huashan Hospital of Fudan University
🇨🇳Shanghai, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
General Hospital of Tianjin Medical University
🇨🇳Tianjin, China
The Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, China
Fakultní nemocnice Brno Neurochirurgická klinika
🇨🇿Brno, Czechia
Fakultní nemocnice u sv. Anny v Brnĕ, Neurochirurgická klinika
🇨🇿Brno, Czechia
Fakultní Nemocnice Plzeň, Neurochirurgicé Oddĕlení
🇨🇿Plzeň, Czechia
Fakultní nemocnice Kralovske Vinohrady
🇨🇿Praha, Czechia
Tampere University Hospital
🇫🇮Tampere, Finland
Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Hôpital Pierre Wertheimer
🇫🇷Bron, France
Centre Hospitalier Universitaire de Grenoble- Hópital Michallon
🇫🇷La Tronche, France
CHRU de Lille- Hópital Roger Salengro
🇫🇷Lille, France
Centre Hospitalier Universitaire de Limoges
🇫🇷Limoges, France
Centre Hospitalier Universitaire Hôpital Nord
🇫🇷Marseille, France
Hópital Central - CHU de Nancy
🇫🇷Nancy, France
Groupe Hospitalier La Salpêtrière
🇫🇷Paris, France
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Klinikum der J.W. Goethe-Universität
🇩🇪Frankfurt, Germany
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Berufsgenossenschaftliche Kliniken
🇩🇪Halle, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Krankenhaus Merheim
🇩🇪Köln, Germany
Universitätsklinikum Gießen und Marburg gGmbH
🇩🇪Marburg, Germany
Klinikum Nürnberg
🇩🇪Nürnberg, Germany
Niels-Stensen-Kliniken
🇩🇪Osnabrück, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Honvédelmi Minisztérium Állami Egészségügyi Központ
🇭🇺Budapest, Hungary
Pécsi Tudományegyetem Általános Orvostudományi Kar
🇭🇺Pécs, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Hungary
Rambam Medical Center
🇮🇱Haifa, Israel
Hadassah Medical Organization
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petach-Tikva, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Chaim Sheba Medical Center
🇮🇱Tel-Hashomer, Israel
Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
🇮🇹Milano, Italy
Fondazione San Raffaele del Monte Tabor
🇮🇹Milano, Italy
Azienda Ospedaliera San Gerardo
🇮🇹Monza, Italy
Azienda Ospedaliero Universitaria Maggiore della Caritá
🇮🇹Novara, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Rome, Italy
Azienda Ospedaliero Universitaria Integrata di Verona
🇮🇹Verona, Italy
Hospital Raja Permaisuri Bainun
🇲🇾Ipoh, Malaysia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Malaysia
Sarawak General Hospital
🇲🇾Kuching, Malaysia
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Spitalul Clinic Judetean de Urgenta Timisoara
🇷🇴Timisoara, Romania
State Budget Educational Institution of Higher Professional Education "Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development"
🇷🇺Kemerovo, Russian Federation
State Professional Institution of High Professional Education "Krasnoyarsk State Medical University named after Prof. V.F. Voyno-Yasenetsky of Ministry of Health and Social Development"
🇷🇺Krasnoyarsk, Russian Federation
State Institution "Burdenko Neurosurgical Institute of RAMS"
🇷🇺Moscow, Russian Federation
State Healthcare Facility "Murmansk Regional Clinical Hospital n.a. Bayandin"
🇷🇺Murmansk, Russian Federation
Saint Petersburg Healthcare Institution "City Mariinsky Hospital"
🇷🇺St. Petersburg, Russian Federation
State Institution of Health Care "Sverdlovsk Regional Clinical Hospital #1"
🇷🇺Yekaterinburg, Russian Federation
National Neuroscience Institute
🇸🇬Singapore, Singapore
National University Hospital
🇸🇬Singapore, Singapore
Singapore General Hospital
🇸🇬Singapore, Singapore
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitario Vall Hebrón
🇪🇸Barcelona, Spain
Hospital Universitario de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
🇪🇸Las Palmas de Gran Canaria, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitari Son Espases
🇪🇸Palma de Mallorca, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Clínico Universitario De Valencia
🇪🇸Valencia, Spain
Hospital Universitari i Politecnic La Fé de Valencia
🇪🇸Valencia, Spain
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Chiang Mai University
🇹🇭Chiang Mai, Thailand
Faculty of Medicine, Prince of Songkla University
🇹🇭Hat yai, Thailand
Khon Kaen Hospital
🇹🇭Khon Kaen, Thailand
Royal Preston Hospital
🇬🇧Fulwood, Preston, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
University Hospital Coventry
🇬🇧Coventry, United Kingdom
Leeds Teaching Hospitals NHS, Leeds General Infirmary
🇬🇧Leeds, United Kingdom
The Royal London Hospital
🇬🇧London, United Kingdom
The James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
Southampton University Hospital
🇬🇧Southampton, United Kingdom